FDA 483 - Henry Okonkwo, P.A. - July 01, 2018

An FDA inspection of Henry Okonkwo, P.A. in Los Angeles, CA, a clinical investigator, revealed a significant issue with incomplete subject case histories. The firm failed to maintain source documentation for specialist assessments, reportedly destroying these documents after e-CRF entry as instructed by a monitor. This practice resulted in e-CRF entries with audit trail timestamps indicating data entry occurred days after subject visits, rather than direct entry.